Effects of fecal microbiota transplantation on cognitive function in type 1 diabetes
Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM: a Randomized Controlled, Triple-blind Clinical Study
This study is testing if a treatment using donated stool can help improve thinking skills in people with long-term type 1 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06496412 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of fecal microbiota transplantation (FMT) in improving cognitive function among patients with long-term type 1 diabetes (T1D). It is a randomized controlled trial with triple blinding, comparing outcomes between an FMT group and a placebo group. The study will assess cognitive function through various scales and brain imaging, as well as monitor other diabetes-related complications and glycemic control. The trial is conducted in two phases, initially recruiting 10 participants followed by an additional 30 participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a diagnosis of type 1 diabetes for at least 10 years and specific glycemic control levels.
Not a fit: Patients who have used non-insulin hypoglycemic medications or participated in other clinical trials recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic options for improving cognitive function in patients with type 1 diabetes.
How similar studies have performed: While the approach of using fecal microbiota transplantation is gaining interest, this specific application in cognitive function for type 1 diabetes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. According to the definition of type 1 diabetes mellitus (T1DM) by the World Health Organization (WHO), the diagnostic criteria are as follows: (i) clinically diagnosed as T1D by endocrinologists; (ii) insulin dependence from disease onset and diabetic ketoacidosis (DKA)/diabetic ketosis (DK) at diagnosis; (iii) positive for at least one of islet autoantibodies for glutamic acid decarboxylase antibody \[GADA\], insulinoma-associated protein 2 antibody \[IA-2A\], and zinc transporter 8 antibody \[ZnT8A\]; or negative for all three islet autoantibodies, but diagnosed before age 30. 2. Age between 18 and 60 years, with a diabetes duration of 10 years or more 3. Glycated hemoglobin levels ranging from 6.5% to 9.0%. Exclusion Criteria: 1. Use of any hypoglycemic medication other than insulin in the two months prior to randomization. 2. Participation in other clinical trials within the two months prior to randomization. 3. Use of antimicrobial drugs, probiotics, intestinal microbiota regulators, and other drugs with significant impact on gut microbiota within the two months prior to randomization. 4. Gastrointestinal diseases: celiac disease, irritable bowel syndrome, Crohn's disease, etc. 5. Severe infections, severe heart, liver, kidney diseases, tumors, and other inflammatory or autoimmune diseases. 6. Pregnant or lactating women, or women planning pregnancy during the study period. 7. Severe mental health disorders such as schizophrenia, major depression, bipolar disorder, alcohol or substance abuse, etc. 8. Neurological disorders such as Parkinson's disease, progressive supranuclear palsy, epilepsy, multiple sclerosis, traumatic brain injury, stroke, etc. 9. Post-implantation of metal materials or contraindications for other MRI examinations. 10. Severe episodes of unconscious hypoglycemia within the past two months.
Where this trial is running
Changsha, Hunan
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Xia Li, MD/PHD — The Second Xiangya Hospital, Central South University
- Study coordinator: Xia Li, MD/PHD
- Email: lixia2014@vip.163.com
- Phone: +86 13974885753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.